(332 days)
Not Found
No
The 510(k) summary describes a dental implant system made of CP Ti Grade 4 with a specific surface treatment. The description focuses on the physical characteristics, sizes, and intended use for prosthetic support. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies described are standard non-clinical tests for medical devices, not studies evaluating AI/ML performance.
Yes
The device is described as an implant system intended to provide prosthetic support for dental restorations, restore chewing function, and replace missing teeth, which are therapeutic functions.
No
This device is a dental implant system intended for prosthetic support and restoring chewing function, not for diagnosing medical conditions.
No
The device description explicitly details physical components made of CP Ti Grade 4, including fixtures of various sizes and lengths, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be surgically placed in the mouth to support dental restorations and restore chewing function. This is a surgical implant, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description details the physical components of a dental implant (fixtures, materials, sizes). It does not describe reagents, calibrators, controls, or other components typically associated with IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
The device is clearly a medical device intended for surgical implantation to replace missing teeth.
N/A
Intended Use / Indications for Use
The Xpeed AnyRidge Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than Ø6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.
Product codes
DZE
Device Description
The Xpeed AnyRidge Internal Implant System contains two types of fixtures, Normal ridge type and low ridge type. The fixtures are made from CP Ti Grade 4, and the surface treatment is done with S.L.A (Sand-blasted, Large grit, Acid-etched). The fixtures are used to replace missing teeth in various situations ranging from a single missing tooth to the completely edentulous individual. The wide ranges of size are provided to be in conformance with each patient, or to cover up in case of due to deficiency in implant operation. The fixture is used as two stages, root-form dental implants, associated with abutment systems, which provide the clinician with the screw and cement retained restoration for multi-mount options. This system has 4.0, 4.4, 5.9mm diameters for normal ridge and 6.4, 6.9, 7.4, 7.9, 8.4mm diameters for low ridge fixtures. In addition, this system has 7.7, 9.2, 10.7, 12.2, 14.2, 17.2mm lengths for normal ridge and 7.9, 9.4, 10.9, 12.4, 14.4mm lengths for low ridge fixtures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary or mandibular molar areas
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test Data: Appearance, Dimension, Packaging, Extraction, and Sterility tests were performed to prove that the modification do not affect the substantial equivalence with the predicate device. Appearance and Dimension test have been performed in accordance with the in-house standard and Packaging test has been performed in accordance with ISO 11607. Those tests have been performed to evaluate the substantial equivalence in size and packaging compared to the predicate device. Extraction and sterility test have been performed in accordance with USP and USP. Those tests have been performed to evaluate the substantial equivalence in the surface characteristics compared to the predicate device. The result of the above tests have met the criteria of the standard, and proved the substantial equivalence with the predicate device. Non-clinical testing consisted of performance of testing in accordance with the FDA guidance "Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, line-art style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 12,2014
MegaGen Implant Company, Limited C/O Ms. Minkyung Hahm Contact/US Agent Kodent, Incorporated 325 North Puente Street, Unit B Brea, California 92821
Re: K140091
Trade/Device Name: Xpeed AnyRidge Internal Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: November 4, 2014 Received: November 4, 2014
Dear Ms. Hahm:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Hahm
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 3 – Ms. Hahm
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Indication for Use
510(K) Number (if known):
Device Name: Xpeed AnyRidge Internal Implant System
Indications for Use:
The Xpeed AnyRidge Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than Ø6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.
Prescription Use X (Part 21 CFR 801 Sub part D)
AND/OR
Over The-Counter Use (21 CFR 807 Sub part C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
4
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Submitter:
Dong Guk Ha MegaGen Implant Co., Ltd. 472, Hanjanggun-ro, Jain-myeon, Gyeongsan-si Gyeongbuk, South Korea Phone: 82-53-857-5770 Fax: 82-53-857-5432
Contact /US agent: Minkyung Hahm KoDent, Inc. 325 N. Puente St. Unit B Brea, CA 92821 Phone: 714-525-0114 Fax: 714-525-0116
Device Information:
Device Name: Xpeed AnyRidge Internal Implant System Classification Name: Implant, Endosseous, Root-Form Common Name: Endosseous Dental Implant Classification: Class II Product Code: DZE Regulation number: 21 CFR 872.3640 Date Prepared: 3/24/2014
Device Description
The Xpeed AnyRidge Internal Implant System contains two types of fixtures, Normal ridge type and low ridge type. The fixtures are made from CP Ti Grade 4, and the surface treatment is done with S.L.A (Sand-blasted, Large grit, Acid-etched). The fixtures are used to replace missing teeth in various situations ranging from a single missing tooth to the completely edentulous individual. The wide ranges of size are provided to be in conformance with each patient, or to cover up in case of due to deficiency in implant operation. The fixture is used as two stages, root-form dental implants, associated with abutment systems, which provide the clinician with the screw and cement retained restoration for multi-mount options. This system has 4.0, 4.4, 5.9mm diameters for normal ridge and 6.4, 6.9, 7.4, 7.9, 8.4mm diameters for low ridge fixtures. In addition, this system has 7.7, 9.2, 10.7, 12.2, 14.2, 17.2mm lengths for normal ridge and 7.9, 9.4, 10.9, 12.4, 14.4mm lengths for low ridge fixtures.
The purpose of this submission is
- to modify the manufacturing process of the fixtures that was mistakenly documented under 510(k) number K122231.
Indication for use
The Xpeed AnyRidge Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than Ø6.0 mm) are dedicated for immediate loading when
5
good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.
Predicate devices
Substantial Equivalence Comparison
The Xpeed AnyRidge Internal Implant System has a substantially equivalent intended use as the identified predicate. The Xpeed AnyRidge Internal Implant System is similar in fundamental scientific technology to the predicate device in that they all have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutments, and they are all constructed of titanium. The subject and predicate device are same in size and materials. When compared with predicate device, no new questions of substantial equivalence have been raised for the Xpeed AnyRige Internal Implant System.
| Subject Device | Predicate Device | ||
|---|---|---|---|
| 510(k) Number | Not available yet | K110955 | K061176 |
| Device Name | Xpeed AnyRidge | ||
| Internal Implant | |||
| System | AnyRige Internal | ||
| Implant System | Straumann Anodized | ||
| Neck Implants | |||
| Manufacturer | MegaGen Implant Co., | ||
| Ltd | MegaGen Implant Co., | ||
| Ltd | Straumann | ||
| Indications for Use | Mandible and Maxilla | ||
| Endosseous Dental | |||
| Implant & Accessories | Mandible and Maxilla | ||
| Endosseous Dental | |||
| Implant & Accessories | Mandible and Maxilla | ||
| Endosseous Dental | |||
| Implant | |||
| Design | Xpeed AnyRidge | ||
| Internal Implant | |||
| System, abutments and | |||
| accessories have been | |||
| designed, manufactured | |||
| and tested in | |||
| compliance with | |||
| FDA's Class II special | |||
| controls guidance | |||
| document root-form | |||
| endosseous dental | |||
| implants and | |||
| endosseous dental | |||
| implant abutments | AnyRidge Internal | ||
| Implant System, | |||
| abutments and | |||
| accessories have been | |||
| designed, manufactured | |||
| and tested in | |||
| compliance with FDA's | |||
| Class II special controls | |||
| guidance document | |||
| root-form endosseous | |||
| dental implants and | |||
| endosseous dental | |||
| implant abutments | -Single-stage | ||
| or two-stage |
- Single-tooth and/or
multiple tooth
applications
-Neck diameter :
3.5mm, 4.8mm |
| Material | CP Ti Grade 4 | CP Titanium, Gr.4 and
Ti-6Al-4V, ELI | CP4 Titanium |
| Sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization |
| Fixture Diameter | Internal type
4.0, 4.4, 4.9, 5.4,
5.9mm
(For normal ridge)
6.4, 6.9, 7.4, 7.9,
8.4mm | Internal type
4.0, 4.4, 4.9, 5.4,
5.9mm
(For normal ridge)
6.4, 6.9, 7.4, 7.9,
8.4mm | 3.3, 4.1, 4.8mm |
6
| Fixture Height | Internal type
7.7, 9.2, 10.7, 12.2,
14.2, 17.2mm
(For normal ridge)
7.9, 9.4, 10.9, 12.4,
14.4mm
(For low ridge) | Internal type
7.7, 9.2, 10.7, 12.2,
14.2, 17.2mm
(For normal ridge)
7.9, 9.4, 10.9, 12.4,
14.4mm
(For low ridge) | 8, 10, 12, 14mm |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Product Code | DZE, NHA | DZE | N/A |
| Surface treatment | SLA | SLA | N/A |
Non-Clinical Test Data
Appearance, Dimension, Packaging, Extraction, and Sterility tests were performed to prove that the modification do not affect the substantial equivalence with the predicate device.
Appearance and Dimension test have been performed in accordance with the in-house standard and Packaging test has been performed in accordance with ISO 11607. Those tests have been performed to evaluate the substantial equivalence in size and packaging compared to the predicate device.
Extraction and sterility test have been performed in accordance with USP and USP.
Those tests have been performed to evaluate the substantial equivalence in the surface characteristics compared to the predicate device.
The result of the above tests have met the criteria of the standard, and proved the substantial equivalence with the predicate device.
Non-clinical testing consisted of performance of testing in accordance with the FDA guidance "Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments."
| Testing Item | References | |
|---|---|---|
| Biocompatibility test | Acute systemic toxicity test | ISO 10993-11 |
| Sensitization test | ISO 10993-10 | |
| Cytotoxicity | ISO 10993-5 | |
| Intracutaneous reactivity test | ISO 10993-10 | |
| Implantation test | ISO 10993-6 | |
| Surface analysis | XPS | In-house standard |
| EPMA | In-house standard | |
| XRD | In-house standard | |
| ICP | In-house standard | |
| SEM | In-house standard | |
| Surface roughness | In-house standard |
The results of the non-clinical testing demonstrate that the subject device is substantially equivalent to the predicate device.
Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification concludes that the Xpeed AnyRidge Internal Implant system is substantially equivalent to predicate devices as described herein.